United States - English - NLM (National Library of Medicine)

aurobindo pharma limited - cefixime (unii: 97i1c92e55) (cefixime anhydrous - unii:xz7bg04gjx) - cefixime anhydrous 100 mg in 5 ml - cefixime for oral suspension is indicated in the treatment of adults and pediatric patients six months of age or older with uncomplicated urinary tract infections caused by susceptible isolates of escherichia coli and proteus mirabilis . cefixime for oral suspension is indicated in the treatment of adults and pediatric patients six months of age or older with otitis media caused by susceptible isolates of haemophilus influenzae , moraxella catarrhalis , and streptococcus pyogenes. (efficacy for streptococcus pyogenes in this organ system was studied in fewer than 10 infections.) note: for patients with otitis media caused by streptococcus pneumoniae , overall response was approximately 10% lower for cefixime than for the comparator [see  clinical studies (14)]. cefixime for oral suspension is indicated in the treatment of adults and pediatric patients six months of age or older with pharyngitis and tonsillitis caused by susceptible isolates of streptococcus pyogenes. (note: penicillin is the usual drug of choice in the treatment of streptococcus pyogenes infections. cefixime for oral suspension is generally effective in the eradication of streptococcus pyogenes from the nasopharynx; however, data establishing the efficacy of cefixime for oral suspension in the subsequent prevention of rheumatic fever is not available.) cefixime for oral suspension is indicated in the treatment of adults and pediatric patients six months of age or older with acute exacerbations of chronic bronchitis caused by susceptible isolates of streptococcus pneumoniae and haemophilus influenzae. cefixime for oral suspension is indicated in the treatment of adults and pediatric patients six months of age or older with uncomplicated gonorrhea (cervical/urethral) caused by susceptible isolates of neisseria gonorrhoeae (penicillinase-and non-penicillinase-producing isolates). to reduce the development of drug resistant bacteria and maintain the effectiveness of cefixime for oral suspension and other antibacterial drugs, cefixime for oral suspension should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antimicrobial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. cefixime for oral suspension is contraindicated in patients with known allergy to cefixime or other cephalosporins. risk summary available data from published observational studies, case series, and case reports over several decades with cephalosporin use, including cefixime, in pregnant women have not established drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see data) . reproduction studies have been performed in mice and rats at doses equivalent to 40 and 80 times, respectively, the adult human recommended dose and have revealed no evidence of harm to the fetus due to cefixime (see data ). the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk maternal gonorrhea may be associated with preterm birth, low neonatal birth weight, chorioamnionitis, intrauterine growth restriction, small for gestational age and premature rupture of membranes. perinatal transmission of gonorrhea to the offspring can result in infant blindness, joint infections, and bloodstream infections. data human data while available studies cannot definitively establish the absence of risk, published data from prospective cohort studies, case series, and case reports over several decades have not identified a consistent association with cephalosporin use, including cefixime, during pregnancy, and major birth defects, miscarriage, or other adverse maternal or fetal outcomes. available studies have methodological limitations, including small sample size, retrospective data collection, and inconsistent comparator groups. animal data the results of embryo-fetal development studies in mice and rats show that cefixime, at doses up to 3200 mg/kg/day administered during the period of organogenesis did not adversely affect development. in these studies, in mice and rats, cefixime did not affect postnatal development or reproductive capacity of the f1 generation or fetal development of the f2 generation. in an embryo-fetal development study in rabbits, cefixime at doses of 3.2, 10 or 32 mg/kg given daily during the period of organogenesis (gestation days 6 through 18) resulted in abortions and/or maternal deaths at doses > 10 mg/kg (typically associated with the administration of antibiotics in this species), but no malformations were reported at lower doses. a pre- and post-natal development study of cefixime at oral doses up to 3200 mg/kg/day in rats demonstrated no effect on the duration of pregnancy, process of parturition, development and viability of offspring, or reproductive capacity of the f1 generation and development of their fetuses (f2 ). risk summary there are no available data on the presence of cefixime in human milk, the effects on the breastfed infant, or the effects on milk production. cefixime is present in animal milk (see data) . when a drug is present in animal milk, it is likely the drug will be present in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for cefixime and any potential adverse effects on the breastfed infant from cefixime or from the mother’s underlying condition. data in a study on disposition of cefixime in pregnant and lactating rats, continuous intra-peritoneal infusion of 2.54 mg/kg/day of 14 c-cefixime from days 10 to 14 postpartum resulted in steady state plasma concentrations of radioactivity in the dams that were 70 times greater than in their nursing pups. after 102 hours of drug infusion, total radioactivity in the body of the pups, including the stomach and intestinal contents, was 1.5% of the 14 c-cefixime estimated to be in the mother's body at steady state.1 safety and effectiveness of cefixime in pediatric patients younger than 6 months of age have not been established. the incidence of gastrointestinal adverse reactions, including diarrhea and loose stools, in the pediatric patients receiving the suspension, was comparable to the incidence seen in adult patients receiving tablets. clinical studies did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently than younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. a pharmacokinetic study in the elderly detected differences in pharmacokinetic parameters [see clinical pharmacology (12.3)] . these differences were small and do not indicate a need for dosage adjustment of the drug in the elderly. the dose of cefixime should be adjusted in patients with renal impairment as well as those undergoing continuous ambulatory peritoneal dialysis (capd) and hemodialysis (hd). patients on dialysis should be monitored carefully [see  dosage and administration (2.3) ].

United States - English - NLM (National Library of Medicine)

lupin pharmaceuticals, inc. - cefixime (unii: 97i1c92e55) (cefixime anhydrous - unii:xz7bg04gjx) - cefixime anhydrous 400 mg - suprax is indicated in the treatment of adults and pediatric patients six months of age or older with uncomplicated urinary tract infections caused by susceptible isolates of escherichia coli and proteus mirabilis . suprax is indicated in the treatment of adults and pediatric patients six months of age or older with otitis media caused by susceptible isolates of haemophilus influenzae , moraxella catarrhalis , and streptococcus pyogenes. (efficacy for streptococcus pyogenes in this organ system was studied in fewer than 10 infections.) note: for patients with otitis media caused by streptococcus pneumoniae , overall response was approximately 10% lower for cefixime than for the comparator [see clinical studies (14)]. suprax is indicated in the treatment of adults and pediatric patients six months of age or older with pharyngitis and tonsillitis caused by susceptible isolates of streptococcus pyogenes. (note: penicillin is the usual drug of choice in the treatment of streptococcus pyogenes infections. suprax is generally effective in the eradication of streptococcus pyogenes from the nasopharynx; however, data establishing the efficacy of suprax in the subsequent prevention of rheumatic fever is not available.) suprax is indicated in the treatment of adults and pediatric patients six months of age or older with acute exacerbations of chronic bronchitis caused by susceptible isolates of streptococcus pneumoniae and haemophilus influenzae. suprax is indicated in the treatment of adults and pediatric patients six months of age or older with uncomplicated gonorrhea (cervical/urethral) caused by susceptible isolates of neisseria gonorrhoeae (penicillinase-and non-penicillinase-producing isolates). to reduce the development of drug resistant bacteria and maintain the effectiveness of suprax and other antibacterial drugs, suprax should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antimicrobial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. suprax  (cefixime) is contraindicated in patients with known allergy to cefixime or other cephalosporins. pregnancy category b reproduction studies have been performed in mice and rats at doses up to 40 times the human dose and have revealed no evidence of harm to the fetus due to cefixime. there are no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. cefixime has not been studied for use during labor and delivery. treatment should only be given if clearly needed. it is not known whether cefixime is excreted in human milk. consideration should be given to discontinuing nursing temporarily during treatment with this drug. safety and effectiveness of cefixime in children aged less than six months old have not been established. the incidence of gastrointestinal adverse reactions, including diarrhea and loose stools, in the pediatric patients receiving the suspension, was comparable to the incidence seen in adult patients receiving tablets. clinical studies did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently than younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. a pharmacokinetic study in the elderly detected differences in pharmacokinetic parameters [see clinical pharmacology (12.3)] . these differences were small and do not indicate a need for dosage adjustment of the drug in the elderly. the dose of cefixime should be adjusted in patients with renal impairment as well as those undergoing continuous ambulatory peritoneal dialysis (capd) and hemodialysis (hd). patients on dialysis should be monitored carefully [see dosage and administration (2.3)] .

United States - English - NLM (National Library of Medicine)

lupin pharmaceuticals, inc. - cefixime (unii: 97i1c92e55) (cefixime anhydrous - unii:xz7bg04gjx) - cefixime anhydrous 100 mg in 5 ml - cefixime for oral suspension and cefixime capsule is indicated in the treatment of adults and pediatric patients six months of age or older with uncomplicated urinary tract infections caused by susceptible isolates of escherichia coli and proteus mirabilis . cefixime for oral suspension and cefixime capsule is indicated in the treatment of adults and pediatric patients six months of age or older with otitis media caused by susceptible isolates of haemophilus influenzae , moraxella catarrhalis , and streptococcus pyogenes . (efficacy for streptococcus pyogenes in this organ system was studied in fewer than 10 infections.) note: for patients with otitis media caused by streptococcus pneumoniae , overall response was approximately 10% lower for cefixime than for the comparator [see clinical studies (14)] . cefixime for oral suspension and cefixime capsule is indicated in the treatment of adults and pediatric patients six months of age or older with pharyngitis and tonsillitis caused by susceptible isolates of

United States - English - NLM (National Library of Medicine)

belcher pharmaceuticals,llc - cefixime (unii: 97i1c92e55) (cefixime anhydrous - unii:xz7bg04gjx) - cefixime anhydrous 100 mg in 5 ml - to reduce the development of drug resistant bacteria and maintain the effectiveness of cefixime for oral suspension and other antibacterial drugs, cefixime for oral suspension should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antimicrobial therapy. in the absence of such data,local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. cefixime for oral suspension is a cephalosporin antibacterial drug indicated in the treatment of adults and pediatric patients six months of age or older with the following infections when caused by susceptible isolates of the designated bacteria: uncomplicated urinary tract infections caused by escherichia coli and proteus mirabilis otitis media caused by haemophilus influenzae , moraxella catarrhalis , and streptococcus pyogenes . (efficacy for

United States - English - NLM (National Library of Medicine)

dr. reddy’s laboratories, inc - cefixime (unii: 97i1c92e55) (cefixime anhydrous - unii:xz7bg04gjx) - cefixime anhydrous 100 mg in 5 ml - to reduce the development of drug resistant bacteria and maintain the effectiveness of cefixime for oral suspension and other antibacterial drugs, cefixime for oral suspension should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antimicrobial therapy. in the absence of such data,local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. cefixime for oral suspension is a cephalosporin antibacterial drug indicated in the treatment of adults and pediatric patients six months of age or older with the following infections when caused by susceptible isolates of the designated bacteria: uncomplicated urinary tract infections caused by escherichia coli and proteus mirabilis otitis media caused by haemophilus influenzae , moraxella ca

United States - English - NLM (National Library of Medicine)

remedyrepack inc. - cefixime (unii: 97i1c92e55) (cefixime anhydrous - unii:xz7bg04gjx) - cefixime is indicated in the treatment of adults and pediatric patients six months of age or older with uncomplicated urinary tract infections caused by susceptible isolates of escherichia coli and proteus mirabilis . cefixime capsules are indicated in the treatment of adults and pediatric patients six months of age or older with pharyngitis and tonsillitis caused by susceptible isolates of streptococcus pyogenes. (note: penicillin is the usual drug of choice in the treatment of streptococcus pyogenes infections. cefixime capsules are generally effective in the eradication of streptococcus pyogenes from the nasopharynx; however, data establishing the efficacy of cefixime capsules in the subsequent prevention of rheumatic fever is not available.) cefixime capsules is indicated in the treatment of adults and pediatric patients six months of age or older with acute exacerbations of chronic bronchitis caused by susceptible isolates of streptococcus pneumoniae and haemophilus influenzae. cefixime capsules is indicated in the treatment of adults and pediatric patients six months of age or older with uncomplicated gonorrhea (cervical/urethral) caused by susceptible isolates of neisseria gonorrhoeae (penicillinase-and non-penicillinase-producing isolates). to reduce the development of drug resistant bacteria and maintain the effectiveness of cefixime capsules and other antibacterial drugs, cefixime capsules should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antimicrobial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.  cefixime capsules are contraindicated in patients with known allergy to cefixime or other cephalosporins. pregnancy category b pregnancy category b. reproduction studies have been performed in mice and rats at doses up to 40 times the human dose and have revealed no evidence of harm to the fetus due to cefixime. there are no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. cefixime has not been studied for use during labor and delivery. treatment should only be given if clearly needed. it is not known whether cefixime is excreted in human milk. consideration should be given to discontinuing nursing temporarily during treatment with this drug. safety and effectiveness of cefixime in children aged less than six months old have not been established. the incidence of gastrointestinal adverse reactions, including diarrhea and loose stools, in the pediatric patients receiving the suspension, was comparable to the incidence seen in adult patients receiving tablets. clinical studies did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently than younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. a pharmacokinetic study in the elderly detected differences in pharmacokinetic parameters [see clinical pharmacology ( 12.3)] . these differences were small and do not indicate a need for dosage adjustment of the drug in the elderly. the dose of cefixime should be adjusted in patients with renal impairment as well as those undergoing continuous ambulatory peritoneal dialysis (capd) and hemodialysis (hd). patients on dialysis should be monitored carefully [see dosage and administration ( 2.3)] .

United States - English - NLM (National Library of Medicine)

remedyrepack inc. - cefixime (unii: 97i1c92e55) (cefixime anhydrous - unii:xz7bg04gjx) - cefixime for oral suspension and cefixime capsule is indicated in the treatment of adults and pediatric patients six months of age or older with uncomplicated urinary tract infections caused by susceptible isolates of escherichia coli and proteus mirabilis . cefixime for oral suspension and cefixime capsule is indicated in the treatment of adults and pediatric patients six months of age or older with otitis media caused by susceptible isolates of haemophilus influenzae , moraxella catarrhalis , and streptococcus pyogenes . (efficacy for streptococcus pyogenes in this organ system was studied in fewer than 10 infections.) note: for patients with otitis media caused by streptococcus pneumoniae , overall response was approximately 10% lower for cefixime than for the comparator [see clinical studies ( 14)] . cefixime for oral suspension and cefixime capsule is indicated in the treatment of adults and pediatric patients six months of age or older with pharyngitis and tonsillitis caused by susceptible isolates of streptococcus pyogenes. (note: penicillin is the usual drug of choice in the treatment of streptococcus pyogenes infections. cefixime for oral suspension and cefixime capsule is generally effective in the eradication of streptococcus pyogenes from the nasopharynx; however, data establishing the efficacy of cefixime for oral suspension and cefixime capsule in the subsequent prevention of rheumatic fever is not available.) cefixime for oral suspension and cefixime capsule is indicated in the treatment of adults and pediatric patients six months of age or older with acute exacerbations of chronic bronchitis caused by susceptible isolates of streptococcus pneumoniae and haemophilus influenzae . cefixime for oral suspension and cefixime capsule is indicated in the treatment of adults and pediatric patients six months of age or older with uncomplicated gonorrhea (cervical/urethral) caused by susceptible isolates of neisseria gonorrhoeae (penicillinase-and non-penicillinase-producing isolates). to reduce the development of drug resistant bacteria and maintain the effectiveness of cefixime and other antibacterial drugs, cefixime for oral suspension and cefixime capsule should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antimicrobial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. cefixime is contraindicated in patients with known allergy to cefixime or other cephalosporins. pregnancy category b . reproduction studies have been performed in mice and rats at doses up to 40 times the human dose and have revealed no evidence of harm to the fetus due to cefixime. there are no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. cefixime has not been studied for use during labor and delivery. treatment should only be given if clearly needed. it is not known whether cefixime is excreted in human milk. consideration should be given to discontinuing nursing temporarily during treatment with this drug. safety and effectiveness of cefixime in children aged less than six months old have not been established. the incidence of gastrointestinal adverse reactions, including diarrhea and loose stools, in the pediatric patients receiving the suspension, was comparable to the incidence seen in adult patients receiving tablets. clinical studies did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently than younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. a pharmacokinetic study in the elderly detected differences in pharmacokinetic parameters [see clinical pharmacology ( 12.3)] . these differences were small and do not indicate a need for dosage adjustment of the drug in the elderly. the dose of cefixime should be adjusted in patients with renal impairment as well as those undergoing continuous ambulatory peritoneal dialysis (capd) and hemodialysis (hd). patients on dialysis should be monitored carefully [see dosage and administration ( 2.3)] .

United States - English - NLM (National Library of Medicine)

northstar rxllc - cefixime (unii: 97i1c92e55) (cefixime anhydrous - unii:xz7bg04gjx) - cefixime for oral suspension is indicated in the treatment of adults and pediatric patients six months of age or older with uncomplicated urinary tract infections caused by susceptible isolates of escherichia coli and proteus mirabilis . cefixime for oral suspension is indicated in the treatment of adults and pediatric patients six months of age or older with otitis media caused by susceptible isolates of  haemophilus influenzae , moraxella catarrhalis , and streptococcus pyogenes . (efficacy for streptococcus pyogenes in this organ system was studied in fewer than 10 infections.) note: for patients with otitis media caused by streptococcus pneumoniae , overall response was approximately 10% lower for cefixime than for the comparator. [ s ee c

United States - English - NLM (National Library of Medicine)

ascend laboratories, llc - cefixime (unii: 97i1c92e55) (cefixime anhydrous - unii:xz7bg04gjx) - cefixime is indicated in the treatment of adults and pediatric patients six months of age or older with uncomplicated urinary tract infections caused by susceptible isolates of escherichia coli and proteus mirabilis . cefixime capsules are indicated in the treatment of adults and pediatric patients six months of age or older with pharyngitis and tonsillitis caused by susceptible isolates of streptococcus pyogenes. (note: penicillin is the usual drug of choice in the treatment of streptococcus pyogenes infections. cefixime capsules are generally effective in the eradication of streptococcus pyogenes from the nasopharynx; however, data establishing the efficacy of cefixime capsules in the subsequent prevention of rheumatic fever is not available.) cefixime capsules is indicated in the treatment of adults and pediatric patients six months of age or older with acute exacerbations of chronic bronchitis caused by susceptible isolates of streptococcus pneumoniae and haemophilus influenzae. cefixime capsules is

Philippines - English - FDA (Food And Drug Administration)

j.m. tolmann laboratories inc. - cefixime (as trihydrate) - suspension, oral - 100mg/5ml